ATX-101 Abdominoplasty (ATX-101-08-10)

This study has been completed.
Sponsor:
Information provided by:
Kythera Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00835952
First received: February 3, 2009
Last updated: January 25, 2010
Last verified: January 2010
  Purpose

Histopathological study of abdominal fat excised from subjects undergoing abdominoplasty


Condition Intervention Phase
Characteristics of Subcutaneous Fat
Drug: ATX-101
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Phase 1, Open-label Study of the Safety, Tolerability, and Histological Effect of Single Doses of ATX-101 (Sodium Deoxycholate for Injection) Administered in Abdominal Fat in Subjects Undergoing Abdominoplasty

Further study details as provided by Kythera Biopharmaceuticals:

Primary Outcome Measures:
  • Adverse events, laboratory test results, physical examinations [ Time Frame: 1 - 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Histopathology [ Time Frame: 1 - 28 Days ] [ Designated as safety issue: No ]

Estimated Enrollment: 14
Study Start Date: November 2008
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ATX-101 Drug: ATX-101
ATX-101 single doses

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects undergoing planned abdominoplasty

Exclusion Criteria:

  • History of interventions in the abdominal area
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00835952

Locations
United States, California
San Francisco, California, United States
Santa Monica, California, United States
Sponsors and Collaborators
Kythera Biopharmaceuticals
Investigators
Study Director: Patricia Walker, M.D., Ph.D. Kythera Biopharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Director, Clinical Affairs, Kythera Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00835952     History of Changes
Other Study ID Numbers: ATX-101-08-10
Study First Received: February 3, 2009
Last Updated: January 25, 2010
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 16, 2014